Shots: The approval is based on the P-III EMPEROR-Reduced trial evaluating the effect of Jardiance (10 mg, qd) vs PBO in 3730 adults with HFrEF with/out T2D The results demonstrated […]readmore
Tags : approval
Shots: The approval is based on two P-III international studies that evaluate cosentyx in pediatric patients aged 6 to <18 yrs. with mod. to sev. PsO who are candidates for […]readmore
Shots: The approval is based on the P-III withdrawal study that evaluates the efficacy and safety of Xywav (twice or once-nightly regimen, oral solution) vs PBO in adults with IH. […]readmore
Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima (18mg) + everolimus (5mg, PO, […]readmore
Shots: The approval is based on P-III safety & efficacy study that evaluates Epidyolex (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment with seizures associated with […]readmore
Shots: The approval is based on the P-III COMET trial that evaluates Nexviazyme (q2w, IV infusion) vs alglucosidase alfa in patients aged ≥1yrs. with LOPD for 49wks. Results: patients achieved […]readmore
In an interview with PharmaShots, Dr. Bassil I. Dahiyat, President and CEO of Xencor shared his views on the company’s collaborations with BMS and its Xtend XmAb technology. He also […]readmore
Shots: The approval is based on P-III UPTRAVI IV study evaluating the safety, tolerability, and PK of temporarily switching Uptravi (PO) to Uptravi (IV) in 20 patients with PAH The […]readmore
Shots: The approval is based on efficacy and safety data from the clinical development program, including two P- III TULIP trials and the P-II MUSE trial evaluating Saphnelo vs PBO […]readmore
In an interview with PharmaShots, Justin Odegaard, Vice President of Clinical Development at Guardant Health shares his views on the Guardant360 CDx approval as the first & only liquid biopsy […]readmore